AML-BFM 2004

Author: Prof. Dr. med. Ursula Creutzig, erstellt 2003/07/24, Last modification: 2012/06/28

AML-BFM 2004 Acute myeloid leukaemia
Disease Acute myeloid leukaemia
Type Multicenter therapy optimising trial for the treatment of Acute myeloid leukeamia
Problem / Objectives

The AML-BFM 2004 trial is an multicenter dose-optimization trial for the treatment of acute myeloid leukeamias in children and adolescents. Patients are treatetd with a combination of intensive chemotherapy in combination with a radiation of the central nervous system (stopped with the amendment of April 2010) and /or haematopoietic stem cell transplantation.
The patients are stratified in a standard-group (SR) and a high risk-group (HR).

Therapy / Study arms

All randomizations are closed in April 2010. The trial is prolonged untill March 2011.
In the SR-Arm all patients receive liposomal daunorubicin. In the HR-Arm all patients receive 2-CDA as intensification during the consolidation course.
The prophylactic radiation of the central nervous system is stopped. The Investigator recommends the implementation of Triple-intrathecal injections.

Inclusion Criteria
  • Age from 0 to 18 years
  • De novo AML, incl. children with Down’s syndrome, primary myelosarcomas or acute mixed lineage leukeamia / biphenotypic leukeamia (predominantly myeloid)
  • Admission to one of the member hospitals in Germany participating in the study AML-BFM 2004
Exclusion Criteria
  • Children with pre-existing syndromes (except Down’s syndrome)
  • AML as secondary malignancy
  • Accompanying diseases which do not allow therapy according to the protocol
  • Pre-treatment for more than 14 days with another intensive induction therapy
Recruitment ca. 550
Status 01.03.2004-30.03.2011. Next trial is in planning stage.
Entry Study Register ClinicalTrials.gov: NCT00111345
Principal Investigator Prof. Dr. med. Dirk Reinhardt, Prof. Dr. Ursula Creutzig
E-Mail AML-BFM@MH-Hannover.DE
URL http://amlstudie.uni-muenster.de/
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Prof. Dr. med. Ursula Creutzig

Documentation

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Weitere Informationen Creutzig U, Buchner T, Sauerland MC, Zimmermann M, Reinhardt D, Dohner H, Schlenk RF. Significance of age in acute myeloid leukemia patients younger than 30 years: a commom analysis of the pediatric trials AML-BFM 93/98 and the adult trials AMLCG 92/99 and AMLSG HD93/98A. Cancer 112: 562-71, 2008

Creutzig U. Treatment of acute myeloid leukemia in children. In: Pui CH, editor. Treatment of Acute Leukemias, New Directions for Clinical Research (St. Jude Children's Research Hospital, Memphis,TN). Totowa, NJ: Human Press Inc, 2003: 237-254

Creutzig U, Zimmermann M, Reinhardt D, Dworzak M, Stary J, Lehrnbecher T. Early deaths and treatment-related mortality in children undergoing therapy for acute myeloid leukemia: analysis of the multicenter clinical trials AML-BFM 93 and AML-BFM 98. J Clin Oncol 2004; 22: 4384-4393

Creutzig U, Zimmermann M, Ritter J, Reinhardt D, Hermann J, Henze G, Jürgens H, Kabisch H, Reiter A, Riehm H, Gadner H, Schellong G. Treatment strategies and long-term results in paediatric patients treated in four consecutive AML-BFM trials. Leukemia: 2005, 19: 2030-2042
Sponsoring Die AML-BFM 2004 trial is financially supported by the Deutsche Krebshife e.V.